Kbi Biopharma | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

Please Wait

Applying Filters...

Find Suppliers : API/FDF
- Search Our Integrated Database
Services
Excipients
NEW Find Prospects
- Prospector
Drugs in Dev.
News
Blog
Market Place
Login

KBI Biopharma
FDA

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Contact Supplier

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Contact Supplier

pharmacompass-1-m-2026-01-12

LEBSA- Your strategic API source for niche molecules.

Contact Supplier

Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

Contact Supplier

pharmacompass-2-m-2025-11-03

KBI Biopharma

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 60 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
60 News #PharmaBuzz

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

SERVICES

Analytical, API Manufacturing

Analytical
- 1 Analytical Method Development
API Manufacturing
- 4 Biologics, Bioprocess & Fermentation

INSPECTIONS & REGISTRATIONS

5 FDA

5 FDA

Xls

Filters

Reset all filters

Filters

FILTER :

filter Legal Name Reset all filters

5 All

01 5KBI Biopharma, Inc.

filter District Decision Reset all filters

5 All

01 4No Action Indicated

02 1Voluntary Action Indicated

filter Inspection End Date Reset all filters

5 All

01 12021-12-03

02 12018-04-11

03 12015-07-16

04 12012-08-29

05 12009-10-09

filter City Reset all filters

5 All

01 1Boulder

02 4Durham

filter Country/Area Reset all filters

5 All

01 5U.S.A

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2021-12-03

KBI Biopharma

City : Boulder

State : Colorado

Country/Area : U.S.A

Zip : 80301

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2021-12-03

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2018-04-11

KBI Biopharma

City : Durham

State : North Carolina

Country/Area : U.S.A

Zip : 27704

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2018-04-11

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2015-07-16

KBI Biopharma

City : Durham

State : North Carolina

Country/Area : U.S.A

Zip : 27704

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-07-16

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2012-08-29

KBI Biopharma

City : Durham

State : North Carolina

Country/Area : U.S.A

Zip : 27704

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-08-29

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2009-10-09

KBI Biopharma

City : Durham

State : North Carolina

Country/Area : U.S.A

Zip : 27704

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-10-09

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

Contact us
to update this info

Privacy policy
Terms and conditions
Disclaimers
Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.